CN1116524A - 盐酸阿夫唑嗪的缓释制剂 - Google Patents

盐酸阿夫唑嗪的缓释制剂 Download PDF

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CN1116524A
CN1116524A CN95104072A CN95104072A CN1116524A CN 1116524 A CN1116524 A CN 1116524A CN 95104072 A CN95104072 A CN 95104072A CN 95104072 A CN95104072 A CN 95104072A CN 1116524 A CN1116524 A CN 1116524A
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alfzosin
hydrochloric acid
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V·安德里尤
J·蒙特尔
A·韦克
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Abstract

盐酸阿夫唑嗪定位释放药剂，包括一种含有活性成分药核，并用溶解度取决于pH值的一种聚合物包衣材料包衣。
制备适于每天服用一次的缓释剂型的用途。

Description

盐酸阿夫唑秦的缓释制剂
本发明涉及盐酸阿夫唑秦(Alfuzosin)的定位释放药剂及其制备每天服用一次的缓释剂型的应用。
盐酸阿夫唑秦口服用于前列腺肥大初期的症状治疗，其吸收浓度表现为沿消化道逐渐降低，在回肠和结肠中的吸收较低。
按照传统的口服剂型，这种化合物的给药必须每天好几次。
对盐酸阿夫唑秦来说，能够足以在24小时内达到持续的血浆浓度的缓释口服剂型必定是主要在消化道的较低部位完成其释放和吸收过程。
根据本发明的新剂型能使盐酸阿夫唑秦在消化道中有目标的释放，并且可以每天口服一次，而且在任何连续快速释放方面都十分安全。
根据本发明，该药剂包括药核，即能提供盐酸阿夫唑秦迅速释放或持续释放的药片或者是能提供盐酸阿夫唑秦迅速释放的微粒，它用一种膜包裹，这种膜的特性和厚度能根据pH和时间来控制活性成分的释放。
提供活性成分迅速或持续释放的这种药片，其所有尺寸都小于10mm，药片中含有3到10％(按重量计)的盐酸阿夫唑秦。
第一种类型的药片是把活性成分和赋形剂如乳糖，微晶纤维素，聚乙烯吡咯烷酮，羧甲基淀粉钠和硬脂酸镁用湿颗粒法制备，第二种类型是把活性成分与一种脂类基质混合用湿颗粒法或熔化法制备，这种脂类基质例如是由微晶纤维素，二水合磷酸二钙，氢化蓖麻油，聚乙烯吡咯烷酮和硬脂酸镁组成。
提供活性成分迅速释放的微粒含有3到15％(按重量计)的盐酸阿夫唑秦，并且尺寸在0.50至1.25mm之间。它是用湿颗粒法由活性成分、甘露醇和聚乙烯吡咯烷酮制备而成的。
然后，在空气流化床设备或其他任一适宜的设备上喷涂一种包裹液把药片和微粒用包衣包被。
该包衣由一种溶解度取决于PH值的聚合物如Eudragit S(甲基丙烯酸共聚物)组成，该聚合物能够形成在PH＝7以上溶解的一种膜，由此达到活性成分在结肠释放。
该包衣的厚度能够使活性成分在PH＝7时释放的潜伏时间得以调整。
就微粒而言，包衣也由一种溶解度取决于PH值的聚合物和一种不透性聚合物，如Eudragit S和乙基纤维素的混合物组成，该聚合物能够使活性成分的释放得以调节，并且能够达到如上所述的释放效果，即由于存在特定PH值下溶解的聚合物和包衣厚度的原因，活性成分的释放取决于pH值和时间。
根据本发明的药剂能够含有3至20mg的盐酸阿夫唑秦。
它们可用于每天只服一次的盐酸阿夫唑秦缓释剂型的制备。
这些剂型能够含有一种或多种具有如上定义的包裹药核药物形式，与一种或多种具有包裹或未包裹的药核的药物形式混合。
这些不同形式的混合能够使在消化道的整个长度内活性成分的释放得以调整。
以下实施例详细说明本发明：
实施例1：作用于结肠的药片药片                  ％(按重量计)盐酸阿夫唑秦              3.3乳糖                     69.4微晶纤维素               17.8聚乙烯吡咯烷酮            5.0羧甲基淀粉钠              4.0硬脂酸镁                  0.5包衣甲基丙烯酸共聚物         75.7二乙酰单甘油酯            7.5滑石                     16.8
实施例2：作用于结肠的微粒微粒                  ％(按重量计)盐酸阿夫唑秦               7.0甘露醇                    32.0微晶纤维素                56.0聚乙烯吡咯烷酮             5.0包衣甲基丙烯酸共聚物              65.0乙基纤维素                    35.0二乙酰单甘油酯                 9.0
实施例3：每天口服一次的硬胶囊药片1号药片                    ％(按重量计)盐酸阿夫唑秦                   3.3微晶纤维素                    30.0二水磷酸二钙                  42.7氢化蓖麻油                    18.0聚乙烯吡咯烷酮                 5.0硬脂酸镁                       1.02号药片盐酸阿夫唑秦                   3.3乳糖                          69.4微晶纤维素                    17.8聚乙烯吡咯烷酮                 5.0羧甲基淀粉钠                   4.0硬脂酸镁                       0.52号药片的包衣甲基丙烯酸共聚物               75.7二乙酰单甘油酯                  7.5滑石                16.8
在PH＝2和PH＝7时进行这些不同药剂的溶解测试，得到下列结果：实施例1的药剂，包衣占药片重量的11％，厚度为100μm。
                   溶解％
时间(小时)     0.5     1.0     2.0     3.0
 PH2     0     0     0     0
 PH7     0     0     30     100
该制剂在酸性PH值时盐酸阿夫唑秦的释放为零而在PH＝7时3小时内完全释放，潜伏时间为1小时，这样能够实现活性成分在结肠得以释放。
通过改变包衣的厚度能够调整活性成分在PH＝7时的释放潜伏时间。
实施例2的制剂，包衣占微粒重量的14％。
                溶解％
时间(小时)     0.5  1      2   3      4   6      8
 PH＝2     0.6  2      7  12     17  26     35
 PH＝7     1  5     23  47     64  83     91
这种制剂中，盐酸阿夫唑秦的释放因PH值的不同而发生变化，从而能够使活性成分的释放率沿整个消化道的长度中有所变化。
实施例3的制剂，2号药片的包衣占该片重量的11％。
                      溶解％
 时间(小时)   0.5  1      2    3      4   6      8
 PH＝2   4  8     13   17     19  22     24
 PH＝7   0.4  4     11   64     89  94     98
该制剂在同一胶囊中结合了两种类型的药片，使得盐酸阿夫唑秦的释放随着PH值的不同而有所变化，因此在整个消化道长度内活性成分的释放率是不同的。
通过增加硬胶囊中作用于结肠的药片数量，在结肠部位所释放的活性成分的量也有所增加。
对本发明药剂的血浆动力学也进行了研究。
在12名健康者中口服按照实施例1的制剂一次后，测定其作用于结肠的药片血浆动力学。
所得结果表明平均5小时后盐酸阿夫唑秦药片到达结肠，最长在11小时内释放完活性成分。该制剂的表观半衰期为9小时。
此外，对按照实施例3制剂的含有盐酸阿夫唑秦药片的硬胶囊的血浆动力学进行了研究。
图1显示了对三种含有不同比例的两类型药片的胶囊测得的结果。
用-□-表示的曲线代表了由1片含有3mg盐酸阿夫唑秦而未包衣的1号药片和3片各含有3mg盐酸阿夫唑秦且包衣的2号药片组成的一种硬胶囊的血浆动力学。
用-○-表示的曲线代表了由1片含5mg盐酸阿夫唑秦而未包衣的1号药片和2片与上述2号药片相同含量且包衣的2号药片组成的一种硬胶囊的血浆动力学。
用-△-表示的曲线代表了由1片含3mg盐酸阿夫唑秦而未包衣的1号药片和2片与上述2号药片相同含量且包衣的2号药片组成的一种硬胶囊的血浆动力学。
结果表明该制剂能够在消化道的整个长度内调整盐酸阿夫唑秦的释放，从而调节其血浆动力学，由于这种释放取决于时间和PH的结合，因此适合于每天服用一次，对于避免任何快速的释放是非常安全的。

Claims (9)

1.盐酸阿夫唑秦的定位释放药剂，其特征在于它包括一种含有活性成分的药核，并用一种溶解度取决于PH值的聚合物包衣材料包衣。
2.根据权利要求1所述的药剂，其特征在于该药核是一种由活性成分和赋形剂组成的药片。
3.根据权利要求1所述的药剂，其特征在于该药核是一种由含活性成分的基质组成的药片。
4.根据权利要求1所述的药剂，其特征在于该药核由微粒组成。
5.根据权利要求1-4中之一所述的药剂，其特征在于溶解度取决于PH值的聚合物是一种甲基丙烯酸共聚物，该共聚物的特性和厚度能使活性成分的释放取决于时间和PH值。
6.根据权利要求4所述的药剂，其特征在于该包衣材料含有乙基纤维素。
7.根据权利要求1-6中之一所述的药剂，其特征在于它含有3-20mg的盐酸阿夫唑秦。
8.盐酸阿夫唑秦的持续释放剂型，其特征在于它包括一种或多种按照权利要求1-7中任一包衣的药核和一种或多种有包衣或未包衣的药核形式。
9.根据权利要求8所述的药剂，其特征在于将不同形式的药核结合在一种单一的硬胶囊中。
CN95104072A 1994-03-21 1995-03-20 盐酸阿夫唑嗪的缓释制剂 Pending CN1116524A (zh)

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CN100335057C (zh) * 1996-08-29 2007-09-05 圣诺菲－安万特 阿夫唑嗪盐酸盐受控释放的片剂
CN100372538C (zh) * 2004-08-30 2008-03-05 鲁南制药集团股份有限公司 盐酸阿夫唑嗪分散片

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FR2752737B1 (fr) * 1996-08-29 1998-10-02 Synthelabo Comprime a liberation controlee de chlorhydrate d'alfuzosine
EP1064938A1 (en) * 1999-06-28 2001-01-03 Sanofi-Synthelabo Pharmaceutical dosage forms for controlled release producing at least a timed pulse
US20040258750A1 (en) * 1999-06-28 2004-12-23 Gerard Alaux Timed dual release dosage forms comprising a short acting hypnotic or a salt thereof
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CZ70495A3 (en) 1995-10-18
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SK36595A3 (en) 1995-11-08
FI951300A (fi) 1995-09-22
AU681236B2 (en) 1997-08-21
HUT72635A (en) 1996-05-28
EP0673650A1 (fr) 1995-09-27
CA2144917A1 (fr) 1995-09-22
ZA952290B (en) 1996-01-24
FI951300A0 (fi) 1995-03-20
AU1495595A (en) 1995-09-28
IL113053A0 (en) 1995-06-29
FR2717388A1 (fr) 1995-09-22
NO951055D0 (no) 1995-03-20
US5589190A (en) 1996-12-31
NZ270748A (en) 1995-12-21
KR950031052A (ko) 1995-12-18
ATE203672T1 (de) 2001-08-15
DE69521924T2 (de) 2002-04-11
HU9500818D0 (en) 1995-05-29
IL113053A (en) 1999-12-22
DE69521924D1 (de) 2001-09-06
FR2717388B1 (fr) 1996-11-22
NO951055L (no) 1995-09-22
JPH07258085A (ja) 1995-10-09

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